Information for Foreign Exporters

Information for Foreign Exporters
FDA’s Import Program
FDA is responsible for enforcing the Federal Food, Drug, and Cosmetic Act (FD&C Act) and
other laws which are designed to protect consumers’ health, safety, and pocketbook. These laws
apply equally to domestic and imported products.
With the exception of most meat and poultry, all food and cosmetics as defined in the FD&C
Act, are subject to examination by FDA when imported or offered for import into the United
States. Most meat and poultry products are regulated by the U.S. Department of Agriculture .
All color additives used in foods and cosmetics in the United States must be approved by FDA;
many cannot be used unless certified in FDA’s own laboratories.
Importing Food Products into the United States
Under provisions of the U.S. law contained in the U.S. Federal Food, Drug and Cosmetic Act,
importers of food products intended for introduction into U.S. interstate commerce are
responsible for ensuring that the products are safe, sanitary, and labeled according to U.S.
requirements. (All imported food is considered to be interstate commerce.)
FDA is not authorized under the law to approve, certify, license, or otherwise sanction individual
food importers, products, labels, or shipments. Importers can import foods into the United States
without prior sanction by FDA, as long as the facilities that produce, store, or otherwise handle
the products are registered with FDA, and prior notice of incoming shipments is provided to
FDA.
Imported food products are subject to FDA inspection when offered for import at U.S. ports of
entry. FDA may detain shipments of products offered for import if the shipments are found not
to be in compliance with U.S. requirements. Both imported and domestically-produced foods
must meet the same legal requirements in the United States.
For an overview of the U.S. Import Program, please visit the links provided below.
http://www.fda.gov/Food/GuidanceRegulation/ImportsExports/Importing/default.htm
Procedures and Requirements for Importing Food Products
In addition to meeting the requirements of U.S. food regulations including food facility
registration, importers must follow U.S. import procedures as well as the requirements of Prior
Notice.
 Import Program
 Prior Notice of Imported Foods
 Chapter 5 – Food, Colors, and Cosmetics
 Imports & Exports Guidance Documents & Regulatory Information
Importing Food Gifts for Personal Use
 Sending Gifts to Your Friends and Family: Prior Notice Policy
 Importing Gift Packs and Prior Notice
 Sending Food through International Mail – Selected Excerpts from the Prior Notice
Interim Final Rule, Guidance Documents, and Fact Sheets
Importing Seafood
 The Imported Seafood Safety Program
All FDA-regulated products imported into the United States are required to meet the same laws
and regulations as domestic goods. Imported foods must be pure, wholesome, safe to eat and
produced under sanitary conditions; drugs and devices must be safe and effective; cosmetics
must be safe for their intended use and properly labeled; radiation-emitting devices must meet
established standards; tobacco products must meet U.S. requirements, and all products must
contain informative and truthful labeling in English.
FDA-regulated products are subject to inspection when offered for import into the United States.
Products may be refused entry if they appear, from examination or otherwise, to violate FDA
requirements. Some products are subject to certification and/or testing requirements due to a past
history of violations; these are identified in import alerts and in certain international cooperative
arrangements.
http://www.fda.gov/InternationalPrograms/ImportsExportsInspections/default.htm
For More Information:
 Federal Food, Drug, and Cosmetic Act, Chapter VIII: Imports and Exports
 Information for Cosmetics Importers
 Importing Food Products into the United States
 Importing Animal Feed
 Importing Veterinary Drugs
 Human Drugs: Imports and Exports Compliance
 CDER Small Business and Industry Assistance: Import and Export of Human Drugs and
Biologics
 Importing CBER-Regulated Products into the United States
 Importing Medical Devices Into the United States
 Importing Tobacco Products
 Import Alerts by Country/Area
 Memoranda of Understanding and Other Cooperative Arrangements
Food Safety Modernization Act (FSMA)
http://www.gpo.gov/fdsys/pkg/PLAW-111publ353/pdf/PLAW-111publ353.pdf
Importing Regulations and Policies (from the website of The US Department of Agriculture)
http://www.usda.gov/wps/portal/usda/usdahome?navid=IMPORTING_GOODS
While foreign regulatory systems need not be identical to the U.S. system, they must employ
equivalent sanitary and health measures that provide the same level of protection achieved
domestically for imported goods.
 Meat, Poultry, and Egg Products Import Regulations and Procedures
 Plant and Animal Import Regulations and Procedures
 Agricultural Permits/ePermits
 Live Animals, Animal Semen, Animal Embryos Import Regulations
 Harmonized Tariff Schedule
 International Phytosanitary Standards Sanitary or Phytosanitary (SPS )
Import Programs
USDA offers import programs to help American agricultural producers compete against the
world market.
 Sugar Import Program
 Dairy Import Licensing Program
 Fruit and Vegetable International Programs
 Livestock and Seed International Programs
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Tariff Information by product
http://www.usitc.gov/tata/hts/bychapter/index.htm
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Chambers of Commerce
https://www.uschamber.com/
http://www.town-usa.com/chambers/chamberlist.html#connecticut
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Research and Reports
Import and Trade Research
USDA provides comprehensive import, trade data, and forecasting
research and reports. Users can utilize the numerous databases to
search by product or country.
 Production, Supply, and Distribution (PSD) Database
 Global Agricultural Trade System (GATS) – Also find previous
Bulk, Intermediate, and Consumer-Oriented (BICO) Statistics
 Trade Data
 Foreign Agricultural Trade of the United States (FATUS)
Database
 Special Outlook Reports
 Trade Policy
 Trade Policy Reports
 Trade News, Trends, and Agreements
 Trade Policy Information by Country
 International Attaché Reports (GAIN)
 Commodity Outlook Reports
 National Center for Import and Export of Animals
 Fruits and Vegetables Import Requirements (FAVIR) Database
USDA Agricultural Projections to 2024, released in February 2015, provides long run
projections for the farm sector for the next 10 years. These annual projections cover agricultural
commodities, agricultural trade, and aggregate indicators of the sector, such as farm income.